When will the FDA’s gluten-free labeling rule go into effect anyway????

Okay, I’m exasperated.   The US Food and Drug Administration was supposed to issue a rule requiring volunteer gluten-free labeling in 2008.  Here it is 2 years past deadline: we’ve elected a new president, we’ve had two postage stamp increases, Britney Spears has gone off the deep end and come back already and we still don’t have this gluten-free rule in place.

So what’s the hold up?

Labeling Allergens

Well first I should explain what I’m even talking about.  In 2004 the Food Allergen Labeling and Consumer Protection Act went into effect.  It forces companies to identify top 8 allergens (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) on their ingredient.  In other words, this why we now see “Contains: Wheat” on many labels.  Before 2004, a lot of of these might be hidden under umbrella terms like “natural flavors”. Because this law doesn’t really cover gluten (which is found in wheat, barley, rye and other derivatives), it had a separate section dealing with that: Section 206, which is quoted below.

“Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall issue a proposed rule to define, and permit use of, the term ‘gluten-free’ on the labeling of foods. Not later than 4 years after the date of enactment of this Act, the Secretary shall issue a final rule to define, and permit use of, the term ‘gluten-free’ on the labeling of foods.”

So the “Not later than 4 years after the date of enactment of this Act….” means not later than 2008.  Which brings me to the beginning of this post again….I’m exasperated…what’s the hold up?

Gluten-Free Labeling Research

Well according to a breakdown available on the Celiac Sprue Association’s website in 2008, the year of the deadline, the 2007 proposed gluten-free rule remained in draft form.  But in 2009 they started studying, taking comments and gathering information from both celiacs, non-celiac gluten-intolerance and people with no connection to either health issue to “gauge perceptions”  of different gluten free claims, like “free of gluten” and “made in a gluten-free facility”. *

Fast forward to April 2010 the FDA posted a survey for people to take to gain “information about the labeling of gluten-free food products and the grocery shopping habits of celiac community,” as quoted by the National Foundation for Celiac Awareness (NFCA).

When will Gluten-Free voluntary labeling be announced?

That brings us to present time.  I sent off an email to the FDA inquiring about the delay. I asked if they could offer someone to talk to me about the status of the gluten-free rule, what are some of the sticking points and when we can expect action.  The answer I received earlier this week from Jeannine Acklin, Consumer Affairs Specialist with the FDA, “…the Agency is working on gluten labeling and will post the final rule in the Federal Register when it is complete.”  Not that different from me telling my kids that “I’ll do something when I’m good and ready!”  Hmmm.

So I dug a little deeper and checked with the company that conducted the survey in April.  I figured if they were still sitting on it then we’d know it’d be a while longer…. Kathy Kosa with the company that conducted the survey told me, “We sent all data to FDA for them to analyze.”

Many advocates for celiac disease are waiting patiently and watching to see what happens.  Alice Bast, Founder and President of NFCA, told me, “we are awaiting the results of the FDA survey that concluded earlier this year. We have yet to receive any new information or updates regarding the status of the FDA’s investigation into the gluten-free labeling on gluten-free products.”  So the FDA appears to be lying very low on this one.  However, Bast adds, the NFCA feels it is making headway and having conversations with the FDA on gluten-free labeling for medications.

Conclusion:  I still have so many questions

Playing devil’s advocate here — maybe the 2008 deadline was unattainable in government time?  Judging from the 30+ page document  on the Proposed Definition of Gluten Free in 2007, and the other paperwork, writing, and bureaucracy they have to go through to make things official, that does take a lot of time.

Plus I am really interested to see how will a VOLUNTARY gluten-free rule for food companies help the celiac cause.  Will the guidelines for gluten expectations empower companies to make their foods gluten free?  Or will they deter companies from claiming gluten-free status?

This story is definitely to be continued…

*Source: FDA Document: Gluten-Free Labeling of Food Products Experimental Study – 2009

January 2011 Update: The American Celiac Disease Alliance is pretty much wondering the same question — when will the FDA get this done?  The ACDA is requesting you send an email to your members of Congress. An easy way to do so– just click here.

Tags: celiac, FDA, gluten-free, government, labeling, law